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CHATTANOOGA FLU110DRecalls & reported problems

Djo, LLC · FLUIDOTHERAPY FT110 SINGLE · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446305132), received between Sep 27, 2021 and Sep 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 27, 2021Patient-Device Incompatibility

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SEVERE, ALLERGIC REACTION AFTER HER FLUIDOTHERAPY TREATMENT.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 12536571 ↗

Other Unit, fluidotherapy devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.